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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012809
Receipt No. R000014941
Scientific Title Effects of optimizing circulatory dynamics on patients outcomes by using a less invasive monitoring device in high-risk surgeries:a pilot study
Date of disclosure of the study information 2014/01/15
Last modified on 2015/08/12

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Basic information
Public title Effects of optimizing circulatory dynamics on patients outcomes by using a less invasive monitoring device in high-risk surgeries:a pilot study
Acronym Circulatory dynamics optimizing study
Scientific Title Effects of optimizing circulatory dynamics on patients outcomes by using a less invasive monitoring device in high-risk surgeries:a pilot study
Scientific Title:Acronym Circulatory dynamics optimizing study
Region
Japan

Condition
Condition Esophageal cancer
Pancreatic cancer
Thoracoabdominal aortic aneurysm
Classification by specialty
Hepato-biliary-pancreatic surgery Vascular surgery Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of intraoperative circulatory management using the parameters of a less invasive monitoring device (FloTrac/Vigileo system) on the patients short term outcomes and the reduction in intra-and postoperative medical care costs.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Postoperative length of hospital stay
Key secondary outcomes Intra-and postoperative medical expenses

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Bolus administration of 200ml of colloid when stroke volume variation is 13% or less
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
95 years-old >=
Gender Male and Female
Key inclusion criteria 1.Patients undergoing surgery due to esophageal cancer, pancreatic cancer, thoracoabdominal aortic aneurysm
2. Patinets of weight >40kg
3. Patients for whom arterial catheter is clinically needed for intraoperative continuous monitoring of arterial pressure.
4. Patients twenty years or older of age when undergoing the operation
Key exclusion criteria 1.Patients under twenty years of age
2.Patients with cardiac arrhythmia
3.Patients of Body Mass Inedex >40
4.Patients undergoing emergency surgeries
5.Patients who have not signed the informed concent
6.Patients undergoing repeat intervention due to postoperative hemorrhage
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyasu Suzuki
Organization Tokai University School of Medicine
Division name department of anesthesia
Zip code
Address 143 Shimokasuya, Isehara, Kanagawa, 259-1193
TEL 0463-93-1211
Email suzuki3@is.icc.u-tokai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Ito
Organization Tokai University School of Medicine
Division name department of anesthesia
Zip code
Address 143 Shimokasuya, Isehara, Kanagawa, 259-1193
TEL 0463-93-1211
Homepage URL
Email itokenji@is.icc.u-tokai.ac.jp

Sponsor
Institute Tokai University School of Medicine department of anesthesia
Institute
Department

Funding Source
Organization Edwards Lifesciences Limited
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東海大学医学部付属病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 03 Month 05 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 06 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 01 Month 10 Day
Last modified on
2015 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014941

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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